DEA making painkillers like Vicodin more difficult to get to curb abuse

NAPLES, Fla. - The U.S. Drug Enforcement Administration is reclassifying painkillers containing hydrocodone, such as Vicodin, to carry stricter prescribing regulations to help curb abuse.

The change will take effect Oct. 6 for prescriptions containing hydrocodone in combination with aspirin or acetaminophen. They will switch from schedule III drugs to schedule II drugs, a designation for substances that have the highest potential for harm and abuse, according to the DEA.

Oxycodone, which gave rise in recent years in Florida to “pill mills” and widespread abuse, is a schedule II drug.

The public knows of hydrocodone combination products through their brand names of Vicodin, Norco, Lortab, and Lorcet and the generic version, said Dr. Dana Castro, staff psychiatrist at the David Lawrence Center in Naples and its residential drug treatment program, Crossroads.

For patients taking Vicodin or generic forms, the change means having to get a written prescription and there are no refills unless a prescribing doctor writes it that way, said Michael Jackson, chief executive officer of the Florida Pharmacy Association.

The pharmacy association is concerned that patients and doctors alike will be given adequate time to transition to the rescheduling, Jackson said.

Prescription drugs infrequently get reclassified and medical providers who tend to long-term care patients with chronic conditions will have to be aware of the change so there’s no lapse in patients being able to access their medications, he said.

“The patient will have to go every 30 days (to the doctor) unless the doctor prescribes it (another) way,” Jackson said. “It will eliminate pharmacies doing refills.”

The state pharmacy association didn’t take a position on the reclassification, he said.

The Florida Medical Association, which represents physicians, likewise didn’t take a position, according to spokeswoman Erika Peterman.

Castro, with David Lawrence, supports reclassifying hydrocodone-containing drugs to schedule II. He believes the move was made because of the U.S. Food and Drug Administration’s approval in October 2013 of the first painkiller made with pure hydrocodone, called Zohydro.

The FDA is anticipating problems with Zohydro and reclassifying hydrocodone combination drugs recognizes them for what they are: a powerful opiate, he said.

“To me, it is clearly not just a coincidence,” Castro said, pointing out that hydrocodone combination painkillers have been schedule III drugs for 15 years.

“I have to give them credit. They are calling a spade a spade by saying this is a dangerous drug,” Castro said.

It’s also unusual for medications to be reclassified, he said.

“It’s definitely better late than never,” he said.

A physician first petitioned in 1999 to change hydrocodone combination drugs to the tougher classification.

The DEA submitted a request to the U.S. Health and Human Services in 2004 for a scientific and medical evaluation, and HHS came back with a recommendation that hydrocodone combination drugs remain schedule III. The federal drug enforcement group asked HHS to re-evaluate their data, according to the Federal Register. In January 2013, the FDA held a public advisory meeting at its headquarters in Silver Spring, Maryland, on the issue. A committee of scientific and medical officials who are considered experts in opioid abuse voted 19-10 in support of the tougher classification. The FDA received 768 comments from patients, advocacy groups and professional societies.

In March 2014, the DEA received 573 comments on its proposed rescheduling of hydrocodone combination drugs, with 52 percent in support and 41 percent opposing while 7 percent didn’t take a definitive position, according to the DEA.

Jackson, with the state pharmacy association, said it’s premature to say if the reclassification will result in reduced abuse of Vicodin and other hydrocodone combination medications.

“Only time will tell,” he said.

That’s also the position of Capt. Harold J. Minch, who heads the organized crime division for the Collier County Sheriff’s Office.

“It’s a good thing. It’s more restrictive but it remains to be seen what it means for law enforcement,” Minch said.

Doctors still have the ability to provide refills after Vicodin and other hydrocodone-containing medications become schedule II and even if a doctor overprescribes, there’s nothing illegal until a patient takes those pills and puts them on the black market, he said.

“Vicodin has always been sold but as we see the other pills go away, you will see some of the others,” he said. “We’ve always seen Vicodin traded. It depends on what (abusers) can get.”

The American Society of Consultant Pharmacists, in Alexandria, Virginia, which works closely with health care entities that take care of the elderly and long-term care patients, said in a statement it is disappointed. The DEA didn’t consider the negative effect for patients from a post-acute care setting or who have long-term pain management needs because they are elderly or have chronic pain.

“DEA’s ruling will magnify existing pain medication access barriers, which currently exist for schedule II drugs in the post-acute and long-term care settings,” Ross Brickley, past president of the group, said in a statement.

Seven million Americans abuse prescription drugs, including synthetic opioids, which result in more deaths from overdoses than auto accidents, DEA administrator Michael Leonhart, said in a statement.

When it comes to teenagers and drug abuse, Vicodin is commonly available in medicine cabinets and can cause them to seek stronger painkillers in a matter of weeks if they are predisposed to getting hooked, said Castro, with David Lawrence.

The acetaminophen with the hydrocodone can cause liver damage, and be fatal, but most abusers know what they can take to avoid liver damage.

That’s because there’s a knowledge base that gets passed down within the drug culture, he said.

“Abusers will take Vicodin right up to the point of treading right up to the edge of liver failure,” he said.

Copyright 2014 Scripps Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Want to participate in the conversation? Log in or become a subscriber today. Subscribers can read and comment on any story, anytime. Non-subscribers will only be able to view comments on select stories.